Dyslipidemia
Conditions
Brief summary
A 12-Week, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study.
Interventions
DRUGPitavastatin
Pitavastatin 4 mg QD
DRUGPravastatin
Pravastatin 40 mg QD
Sponsors
Kowa Pharmaceuticals America, Inc.
Eli Lilly and Company
Kowa Research Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Males and females (non-pregnant, non-lactating females) 18-70 years of age, inclusive, at time of consent. * Both men and women of child bearing potential (i.e., not surgically sterile or post-menopausal defined as age \>40 years without menses for ≥2 years) must agree to use at least 2 reliable forms of contraception * Documented HIV infection.
Exclusion criteria
* Homozygous familial hypercholesterolemia * Any conditions that may cause secondary dyslipidemia * History of coronary artery disease (CAD) or CAD equivalent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks | 12 weeks minus baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pitavastatin 4 mg QD Pitavastatin: Pitavastatin 4 mg QD | 126 |
| Pravastatin 40 mg QD Pravastatin: Pravastatin 40 mg QD | 126 |
| Total | 252 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 6 | 6 |
| Overall Study | Lost to Follow-up | 5 | 11 |
| Overall Study | Other | 2 | 0 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Protocol Violation | 8 | 7 |
| Overall Study | Sponsor Decision | 2 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 9 |
Baseline characteristics
| Characteristic | Pitavastatin 4 mg QD | Pravastatin 40 mg QD | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 126 Participants | 126 Participants | 252 Participants |
| Region of Enrollment United States | 126 participants | 126 participants | 252 participants |
| Sex: Female, Male Female | 20 Participants | 15 Participants | 35 Participants |
| Sex: Female, Male Male | 106 Participants | 111 Participants | 217 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 126 | 5 / 126 |
| serious Total, serious adverse events | 7 / 126 | 3 / 126 |
Outcome results
Primary
Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks
Time frame: 12 weeks minus baseline
Population: modified Intent To Treat (mITT) population included all randomized subjects who received at least 1 dose of study drug and had at least 1 on-treatment lipid assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pitavastatin 4 mg QD | Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks | 155.1 mg/dL | Standard Deviation 25.93 |
| Pravastatin 40 mg QD | Change of Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at 12 Weeks | 154.6 mg/dL | Standard Deviation 23.91 |